Paradromics announced today that it selected a third investigator for its upcoming brain-computer interface (BCI) clinical study.
Austin, Texas-based Paradromics announced the first two investigators — Dr. David Brandman and Dr. Daniel Rubin — in March. Today, the company added Dr. Matthew Willsey as an investigator for the “Connect-One” study. Willsey, a neurosurgeon, holds dual faculty appointments in Neurosurgery and Biomedical Engineering at the University of Michigan.
Last month, Willsey and his team demonstrated that the Paradromics Connexus BCI can be safely implanted in a human, record brain signals, and be removed intact in less than 20 minutes, a major milestone marking Paradromics’ transition to a clinical-stage company.
(Learn more about the BCI space here. Analysts view a massive market opportunity for the technology.)
Connexus has the potential to help patients communicate after losing the ability to speak and control computer devices. It translates recorded brain signals into actionable health data. Initial focus centers around restoring independent communication through digital devices. It targets individuals living with spinal cord injuries, stroke, or ALS, a motor neuron disease.
With three clinical sites (Davis, California, Boston, Massachusetts, and Ann Arbor, Michigan), the trial expands to serve both coasts and the midwest. The study evaluates the safety of the novel device and is expected to kick off later this year, following regulatory approval.
“Dr. Willsey is a remarkable addition to the Connect-One clinical research team,” said Matt Angle, Ph.D., founder and CEO of Paradromics. “His intracortical BCI research at the University of Michigan’s Willsey Lab is closely aligned with Paradromics’ mission to create life-improving neurotechnology that delivers precision digital medicine for people with neurological disorders.”
Paradromics received acceptance into the FDA Total Product Life Cycle Advisory (TAP) program in July 2024. In preparation for a clinical trial in 2025, the company also launched a patient registry so patients can submit interest. It featured on MassDevice’s 2024 lists of BCI companies to know and neurotech companies to know.
